Abuzzahab 1982.
Methods | Randomisation: implied randomisation. Blinding: double‐blind. Duration: 24 weeks. Design: parallel. Location: not indicated. Setting: outpatients. |
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Participants | Diagnosis: schizophrenia. N = 57. Gender (N = 46): 20M, 16F. Age: mean 35.5 years. History: duration stable: not indicated, duration of illness: mean 9 years, number of previous hospitalisations: not indicated, age at onset: not indicated, severity of illness: not indicated, baseline antipsychotic dose: not indicated. |
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Interventions | 1. Haloperidol: fixed/flexible dose: not indicated, dose range: 5 mg to 40 mg/day, mean dose: 17.5 mg/day. N = 22. 2. Thiothixene: fixed/flexible dose: not indicated, dose range: 10 mg to 80 mg/day, mean dose: 31.8 mg/day. N = 24. Rescue medication: “Antiparkinsonian drugs were permitted” |
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Outcomes | Examined: Leaving the study early due to any reason. Adverse effects: at least one adverse effect, akathisia, rigor, tremor, weight gain. Unable to use: Clinically important response to treatment: Investigator global evaluation (no raw data available). Global state general: Evaluation of Social Functioning (ESFR) (no total score available, no SDs available). Mental state general: Brief Psychiatric Rating Scale (BPRS) (no SDs available and no imputation method could be applied). Mental state specific: Hamilton Psychiatric Rating Scale for depression (HPRSD) (no SDs available and no imputation method could be applied). Mental state specific: ZUNG scale (self‐rating depression scale) (no raw data available). Behaviour: Nurses´ Observation Scale for Inpatient Evaluation (NOSIE) (mentioned in the abstract, but not in the methods and results section of the publication). |
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Notes | 57 participants were randomised, but participants were only included in the analyses if they “had at least 10 days of therapy.” | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No randomisation mentioned in the publication, but the trial was described as “double‐blind.” Thus, it was implied that the study was randomised. |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding (performance bias and detection bias) (performance bias) | Low risk | “Double‐blind”. “The study medications were administered as identical‐appearing capsules.” |
Blinding (performance bias and detection bias) (detection bias) | Unclear risk | “Double‐blind”. No further details. |
Incomplete outcome data (attrition bias) All outcomes | High risk | The overall‐attrition was high: 31 of 57 participants (54.4%) left the trial early. The trial authors indicated that 15 of 29 participants (51.7%) in the haloperidol‐group and 16 of 28 participants (57.1%) in the thiothixene‐group discontinued the drug treatment prematurely. Modified completers analyses were used (“all patients evaluated had at least 10 days of therapy”). |
Selective reporting (reporting bias) | High risk | The outcome data were not fully addressed (no total score or SDs for the BPRS, HPRSD, ESFR, and investigator global evaluation; no raw data for the ZUNG scale; the NOSIE scale is mentioned in the abstract but not in the methods and results section of the publication). There was no information regarding the number of participants who received a medication with antiparkinson drugs in each group; only for the whole study sample of the 46 analysed participants. |
Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists. |